FDA 510(k) Application Details - K012141

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K012141
Device Name	Device, Counter-Pulsating, External
Applicant	EXTERNAL COUNTERPULSATION LAB BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST. KFAR SABA 44425 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN Other 510(k) Applications for this Contact
Regulation Number	870.5225   More FDA Info for this Regulation Number
Classification Product Code	DRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2001
Decision Date	10/25/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review